AURIMUNE: A NANOMEDICINE PLATFORM

A tumor is a fortress whose defenses can block chemotherapies from reaching the cancer cells growing inside. To expose cancer cells to cancer cell killers, the nutritional support structures and protective barriers of tumors must first be destroyed.

CytImmune’s nanotherapy platform, Aurimune, is a tumor-targeted Trojan horse. It is engineered to travel safely and stealthily through the body and enter tumors through their most vulnerable points – the leaky blood vessels that make up the nutritional support structures. Aurimune selectively binds TNF receptors on blood vessel cells at the site of disease. Once bound, Aurimune unleashes a therapeutic payload that destroys the tumor’s nutritional support structures and protective barriers.

This “opens the gate” for cancer cell killers to penetrate the tumor and eradicate disease.

Breaking Down the Fortress

Anti-cancer agents can't penetrate tumor defenses.Read More
Tumors have blood vessels that are abnormally porous. These leaky blood vessels form the nutritional support structures that enable tumors to absorb fluids to feed cancer cell growth with no efficient route for exit, thereby creating a protective pressure gradient inside the tumor (like inflating a balloon), but outside the blood stream itself. This protective pressure gradient effectively blocks anti-cancer agents from reaching their target – the cancer cells inside the tumor.

Watch our technology video.
Tumor Necrosis Factor destroys tumor defenses.Read More
It’s widely known and accepted that a naturally occurring molecule, tumor necrosis factor (TNF), which is part of our own immune system, is capable of destroying the nutritional support structures (leaky vasculature) of tumors, and in doing so, removes the protective pressure barrier of tumors.

Watch our technology video.
Aurimune delivers TNF safely and effectively.Read More
As demonstrated in numerous clinical settings, local administration of TNF at the site of disease normalizes blood flow through tumors, exposing cancer cells to cancer cell killers as all pressure resistance is gone. But TNF’s inherent toxicity has prevented it from being used systemically to treat cancer patients -- until now.

Aurimune safely delivers TNF systemically to tumors at clinically effective levels with no dose limiting toxicity.

Watch our technology video.

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- Dr. John Doe, MD
Montefiore Medical Center

Tumor-Targeted Trojan Horse

Aurimune travels through the body by stealth.Read More
A water shield surrounds the Aurimune nanoparticle and hides its toxic payload. This water shield is created through a peg-thiol technology and prevents toxics substances – like TNF – from reaching and damaging healthy blood vessels and tissues. Collateral damage of this type is typically the underlying cause of dose limiting toxicity for most chemotherapy. The Aurimune water shield also allows the nanotechnology to evade immune detection, allowing the nanomedicine to pass through the circulatory system and access tumors through their unique biological support structures (leaky blood vessels).

Watch our technology video.
Aurimune is highly targeted to tumors.Read More
Aurimune exits the circulation only at the site of disease as it is precisely sized to pass through the abnormally large gaps found in tumor blood vessels.

Watch our technology video.
Aurimune “opens the gate” allowing chemo to work. Read More
Upon reaching its pre-determined target, Aurimune selectively binds to specific TNF receptors of blood vessel cells at tumor sites and then exerts its biologic action, which destroys the nutritional support structures and protective pressure barriers of tumors. This “opens the gate” for cancer cell killers to freely penetrate the tumor and eradicate disease.

Watch our technology video.

- Dr. John Doe, MD
Montefiore Medical Center

Enabling Cancer Cures

After treatment, cancer cell killers can enter the tumor.Read More
When the tumor support structure (blood vessels) is destroyed, the positive pressure gradient that protects cancer cells inside the tumor is removed and cancer cells are then exposed to cancer cell killers (follow-on therapies) as blood flow through the tumor is normalized.

Watch our technology video.
Aurimune, CYT-6091, is already in clinical trials.Read More
CYT-6091 is the first in a family of neo-adjuvant, Aurimune-based nanotherapies designed to amplifiy the effectiveness of either follow-on administration of chemotherapy or anti-cancer agents bound to nanoparticle itself.

Watch our technology video.
The possibilities are limitless.Read More
Cytimmune has successfully attached both biological and small chemical anti-cancer agents to the Aurimune delivery platform and has proven that cancer cell-killing therapies can be delivered along with TNF to open up tumors and destroy the cancer cells inside.

Watch our technology video.

- Dr. John Doe, MD
Montefiore Medical Center

THE ELEMENTS OF AURIMUNE

CytImmune created Aurimune to make a quantum leap forward in the technology available to safely and effectively deliver a range of anti-cancer therapies into tumors.

Gold-based nanotechnology

The center of the Aurimune platform is a precisely sized gold nanoparticle. Sizing is optimized to leverage the inherent leakiness of tumor blood vessels. Gold has low toxicity and regulators understand its safety profile since it has been used therapeutically in humans for decades.

PolyEthylene Glycol

PEG is a water-absorbing molecule that covers the gold particle like tiny hairs and is key to the stealthy nature of the Aurimune platform. PEG attracts and holds a protective water shield around the nanotherapy as it passes through the body. This creates the “water shield” that surrounds the nanomedicine.

Tumor Necrosis Factor

TNF breaks down the blood vessel architecture inside tumors. This makes the cancer cells inside the tumor vulnerable to anti-cancer agents.

Proprietary Linkers

CytImmune developed patented linker technology to attach small molecule, anti-cancer agents directly to the Aurimune nanomedicine. These linkers are unique and can be adjusted to work with a variety of agents targeting multiple tumor types.

Optional Cancer-Cell-Killing Agent

Other biological or chemical anti-cancer agents can be added to the core Aurimmune nanomedicine. They can be precisely delivered to kill growing cancer cells inside the tumor.

AURIMUNE PLATFORM PRODUCTS

Clinical Trials

CYT-6091

A first generation Aurimune platform nanotherapy, CYT-6091, carries TNF into tumors to disrupt their blood vessels and enable follow-on chemotherapy to penetrate the tumor and kill the cancer cells inside. In a successful Phase I clinical trial, CYT-6091 safely delivered what would have been a toxic but highly effective dose of the anti-cancer agent TNF to patients; dose levels were three times the previous maximum tolerated dose. Tissue samples, taken 24 hours after CYT-6091 administration, showed that the nanomedicine had concentrated inside tumor tissues, not inside surrounding healthy tissue.

A Phase II clinical trial will treat non-small lung cancer patients in combination with standard of care second line therapy. Additional details related to the Phase II trial will be announced.

Preclinical Studies

CYT-21000

A second generation Aurimune platform nanomedicine, CYT-21000, carries Taxol (paclitaxel) in addition to TNF. Aurimune is currently the only nanotechnology that has been able to simultaneously deliver a biologic, TNF, and a small molecule therapeutic, Taxol, carried by the same nanoparticle.

Discovery

AstraZeneca Partnership

CytImmune is currently working with AstraZeneca’s Oncology Innovative Medicines Unit to examine the viability of delivering one or more AstraZeneca anti-cancer therapies into solid tumors using the Aurimune nanomedicine platform.

Other CytImmune Investigations

CytImmune has successfully linked other anti-cancer agents to the Aurimune platform. These include:

Interferon (CYT-61000)
Gemcitabine (CYT-71000)

PARTNERING WITH CYTIMMUNE

The Aurimune nanomedicine platform offers the potential to enable and/or expand the clinical benefit of a variety of toxic anti-cancer therapies -- either as monotherapies or in combination with existing standards of care. Aurimune functions are independent of tumor-specific biochemistry; therefore it does not depend on the type of cancer treated.

However, since cancer is not a single disease, CytImmune has developed a pipeline of Aurimune-based products to attack cancers through different biologic pathways.

CytImmune and the Aurimune platform offer unique advantages including:

- The only clinical stage tumor-targeted product that can carry both biologics and small molecule therapeutics;
- Experience with numerous therapeutic classes of drugs enabling them to bind to the Aurimune platform; and
- A successful track record working with other institutions to integrate existing anti-cancer agents onto the Aurimune nanomedicine, rescuing molecules whose systemic toxicity has stifled clinical development.

CytImmune is open to investigating potential partnerships. For more information, contact Mitchell Marder at (301) 825-3041.

NEWS & UPDATES

ABOUT CYTIMMUNE

Founded in 1988, CytImmune has transitioned from a successful diagnostics company into a clinical stage nanomedicine company with a core focus on the discovery, development and commercialization of multifunctional, tumor-targeted therapies.

CytImmune is a global leader in the field of nanomedicine with the successful completion of a Phase I clinical trial of CYT-6091 — the first in a series of products based on the CytImmune’s Aurimune nanomedicine platform. The company has more than 60 issued and pending patents for its colloidal gold nanotechnology in the United States, European Union, Japan and Canada.

MANAGEMENT TEAM

Lawrence Tamarkin, Ph.D.
Co-Founder, President & CEO, Chairman of the Board

Mitchell S. Marder
Executive Vice President, Corporate Development and Chief Legal Officer

Gary Rosenfeld
Chief Financial Officer

David Oarr
Senior Director, External and Executive Communications
Press Contact

BOARD OF DIRECTORS

Robert Ashton, MD
Thoracic surgeon and consultant to financial institutions

Neal Cohen
Vice Chairman, Board of Directors and President, Global Client Strategy, APCO Worldwide

John Holaday, Ph.D.
Executive Chairman of ExoCyte Therapeutics Pte. Ltd.

Ken Itani
Group General Manager, Itanis International, Inc.

Ira Shapiro
President, Ira Shapiro Global Strategies, LLC

Marc Stanley
Former Acting Deputy Director, National Institute of Standards and Technology

SCIENTIFIC ADVISORS

Prof. Alexander M.M. Eggermont, M.D./Ph.D
Director General, Cancer Institute Gustave Roussy, Paris France

David G. I. Kingston, Ph.D
Director, Virginia Tech Center for Drug Discovery, VA USA

Steven K. Libutti, M.D., FACS
Director, Montefiore Einstein Center for Cancer Care, NY USA

Prof. Kouji Matsushima, M.D., Ph.D.
Department of Molecular Preventive Medicine, University of Tokyo, Tokyo, Japan

INQUIRIES

For additional information on CytImmune or the Aurimune nanomedicine platform, contact us at:

CytImmune Sciences
15010 Broschart Road
Rockville, MD 20850

Phone: (301) 825-3041